MAUDE Adverse Event Report: I.T.S. GMBH FLS PLATE, STRAIGHT, 6-HOLE

Model Number	21421-6
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the straight fls plate (21421-6) was inspected and showed no deviations.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.The plate broke, as the female patient with an approx.Weight of (b)(6) lbs load the injured foot completely.Furthermore, the reduction of the fracture is not sufficient (oa dr.(b)(6)).
Event or Problem Description
It was reported that a fls plate, straight, 6-hole was determined to be broken postoperatively.Original implant date unknown.A revision surgery was performed on an unknown date.

• Brand Name: FLS PLATE, STRAIGHT, 6-HOLE
• Common Device Name: FLS PLATE, STRAIGHT, 6-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8225838
• Report Number: 3004369035-2015-00005
• Device Sequence Number: 19399700
• Product Code: HRS
• UDI-Device Identifier: 09120047299333
• UDI-Public: 09120047299333
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K131722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 21421-6
• Device Catalogue Number: 21421-6
• Device Lot Number: 26/F32179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2015
• Initial Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 120